BEUDAMED
    26 results · 15ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

    FDA Enforcement
    Class II ·Terminated·EMG Technology Co., Ltd.·September 24, 2014

    Axiom Aristos MX/VX. Model number 58 95 003

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPR·June 10, 2005

    Axiom Aristos FX. Model number 74 14 803

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPR·June 10, 2005

    Axiom Aristos TX. Model number 58 94 873 Radiology system

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPR·June 10, 2005

    Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 17, 2013

    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

    FDA Recall
    Terminated ·EMG Technology Co., Ltd.·Product code JCX·August 3, 2014

    Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code MUE·February 28, 2013

    AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FKX·December 11, 2018

    Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FKX·December 11, 2018

    Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00 -VersaSafe Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 2120-0500, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-01104 Rev 00 -SmartSite Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump REF 2420-0500,WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-00952 Rev 01 -Infusion Set Alaris Pump Module/Medley Pump Module REF 24009-0007T, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN, FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion 630-00650 Rev 00 Production Usage: Administration sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein. The sets are comprised with components commonly found on intravascular administration sets and extension sets. The components include an Alaris Pump module silicone segment and fitments, drip chamber, check valve, one or more SmartSite needleless connectors, slide clamp, male luer with spin lock and tubing with different length of tubing.

    FDA Enforcement
    Class II ·Terminated·CareFusion 303, Inc.·November 14, 2018

    STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code DSS·January 31, 2020

    Discovery Channel brand 8-Way Massager with Heat; therapeutic massager; Wahl Clipper Corporation, Sterling, IL 61081, made in China

    FDA Recall
    Terminated ·Wahl Clipper Corp·Product code ISA·December 10, 2004

    Wahl 2-Speed All-Body Massager, model 4120-1; therapeutic massager; Wahl Clipper Corporation, Sterling, IL 61081, made in China; Please note: Wahl sells these massagers under other model numbers based on the packaging configuration. All packages contain the model 4120-1 massager, with various attachments. These package models include 4120-200 and 4120-217

    FDA Recall
    Terminated ·Wahl Clipper Corp·Product code ISA·November 1, 2005

    Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels.

    FDA Recall
    Terminated ·Sybaritic, Inc·Product code ISA·June 18, 2008

    WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to relieve minor muscle aches and pains.

    FDA Recall
    Terminated ·Wahl Clipper Corp·Product code ISA·December 15, 2020

    STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code DSS·January 31, 2020

    Wahl 2-Speed All-Body Massager with Heat and Discovery Channel brand 8-Way Massager with Heat, model 4196-1; therapeutic massager; Wahl Clipper Corporation, Sterling, IL 61081, made in China; Please note: Wahl sells these massagers under other model numbers based on the packaging configuration. All packages contain the model 4196-1 massager, with various attachments. These package models include 4196-500, 4196-517 and 4196-519

    FDA Recall
    Terminated ·Wahl Clipper Corp·Product code ISA·November 1, 2005

    Shoulder Flex Massage Device Device is an electric personal massage device labeled in part: "ShoulderFlex Deep-kneading Shiatsu* Model #SH61 *Read all instructions before using the massager* **WARNING NEVER wear a necklace or similar items while using this product Made in China." Personal use massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while user lies on a flat surface.

    FDA Recall
    Terminated ·King International·Product code ISA·August 30, 2011

    STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code DSS·January 31, 2020

    STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code DSS·January 31, 2020